Quality Management Systems

Could an overhaul in the Quality Management of Medical Equipment be the answer to tackling future racial bias in the Healthcare Sector?

In light of last weeks concerns around the way medical devices may have ethnic bias, we’re pleased to read at Konsolute that a far-reaching UK led review has been promised by the end of January 2022. The review, it claims, will drive forward new international standards to improve healthcare and tackle dangerous disparity.

A Chance for Change

As Quality Management System developers, we believe there is a chance here for the UK medical industry to take a hold of its CAPA and PDCA processes and make real changes to the way it reviews and regulates its devices. Aside from medical equipment, the coronavirus (COVID-19) pandemic has exposed health disparities across the country as the virus had a greater impact on those whose underlying health was poorer and death rates have been higher among people from ethnic minority communities.

It’s clear that a part of the issue lies with UK regulators who despite setting clear expectations, do not provision for the impact of demographic factors when it comes to devices. With this in mind, medical standards need to be expanded and developed to cater for the diversity of patients they are treating. If UK regulators can set new benchmarks, device manufacturers will have a better steer on product development.

What will the Review Cover?

So will this independent review be a gamechanger? From what we know so far, the investigation will look at devices such as oximeters – used to measure oxygen levels – to identify potential discrepancies in how they work for different ethnic groups. Of course the main driver of this review is the connection with skin colour.

The review will focus on whether existing regulations mean there is a systemic bias inherent in medical devices. This comes after some alarming research that concluded darker skinned patients in need of hospitalisation are at greater risk of inaccurate results from oximeters due to a tendency for this group to present higher levels of oxygen in their blood.

It has also been suggested that government ministers will use this review as an opportunity to look into other known demographic related issues- pregnant women and MRI scans being one example given.

A History of Poor CAPA Processes

Having worked with the healthcare sector on quality management projects, we understand the critical nature of compliance in the medical industry. We’re also aware that as a public sector industry, medical staff and the organisations they work for are incredibly busy and overworked. This, unsurprisingly can lead to gaps in best practice. In fact, Device makers have historically struggled to maintain adequate procedures for corrective and preventive action (CAPA) and complaint handling (CH), and two warning letters posted to the FDA website suggest these are still sore spots. Invacare Corp., of Elyria, Ohio, and Smiths Medical ASD Inc., of Minneapolis, were both cited for CAPA and CH deficiencies.

Government Response

Health minister, Mr. Javid said he is ‘determined to take a fresh perspective’ to his role within Government and ‘do whatever it takes’ to fix disparities, citing the disproportionate effect of the pandemic on black, Asian and other minority ethnic groups. We certainly hope, starting with better quality management and thorough CAPA processes will be something that he chooses to focus on over the coming months. Are you in the medical industry and looking for a QMS system, give us a call we love talking to fellow cloud enthusiasts.

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